The Central Drugs Standard Control Organisation (CDSCO) has issued a circular on the launch of the online system Post Approval Changes (PAC) with respect to Marketing Authorisations (MAs) for human vaccines and anti-sera. This circular was issued on 10th November, 2023.
With the introduction of the online system of SUGAM portal, the CDSCO seeks to streamline the regulatory submission procedure.
It may be recalled that CDSCO had already launched the online system of applications for the following submissions:
- PAC for clinical trials of vaccines in form CT-06
- Approval for protocol
- Approval for report of Post Marketing Surveillance (PMS) study for human vaccines and anti-sera
Now, by the present circular, this facility has been extended to MAs for human vaccines and anti-sera.
All applicants must apply through the online portal as per the checklist provided in the module.
It is important to note that the facility for offline submission of applications in hard copy will not be available from 1st December, 2023. The offline facility has already been terminated for PAC for clinical trials in vaccines in form CT-06 and approval for protocol/ report of PMS study for human vaccines and anti-sera.